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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Attachment, Breathing, Positive End Expiratory Pressure
510(k) Number K900164
Device Name AIRWAY DELIVERY & MANAGEMENT (ADAM) NASAL VENTILA.
Applicant
PURITAN BENNETT CORP.
9401 INDIAN CREEK PKWY.
P.O. BOX 25905
OVERLAND PARK,  KS  66225
Applicant Contact MARSHALL SMITH
Correspondent
PURITAN BENNETT CORP.
9401 INDIAN CREEK PKWY.
P.O. BOX 25905
OVERLAND PARK,  KS  66225
Correspondent Contact MARSHALL SMITH
Regulation Number868.5965
Classification Product Code
BYE  
Date Received01/12/1990
Decision Date 01/26/1990
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
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